A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

Purpose

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Condition

  • Alzheimer Disease

Eligibility

Eligible Ages
Between 55 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1). - Patients who are diagnosed with AD based on the 2024 National Institute on Aging - Alzheimer's Association criteria with AD biomarker confirmation. - Patient must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma. - Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).

Exclusion Criteria

  • Patients will not be able to participate if they have:. i) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features. ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KarXT
  • Drug: KarXT
    Specified dose on specified days
    Other names:
    • BMS-986510
Experimental
Placebo
  • Drug: Placebo
    Specified dose on specified days

Recruiting Locations

Chandler Clinical Trials, LLC
Chandler 5289282, Arizona 5551752 85224
Contact:
Muhammad (Osman) Salim Khan, Site 1227
480-716-4590

Gilbert Neurology Partners - PLLC - Avacare
Gilbert 5295903, Arizona 5551752 85297
Contact:
Jonathan Hodgson, Site 1247
602-761-9631

Banner Alzheimer's Institute
Phoenix 5308655, Arizona 5551752 85006-2528
Contact:
Ganesh Gopalakrishna, Site 1217
602-839-6900

Scottsdale Clinical Trials
Scottsdale 5313457, Arizona 5551752 85260-6742
Contact:
Khalid Salim, Site 1220
480-382-7909

Advanced Research Center, Inc.
Anaheim 5323810, California 5332921 92805-5854
Contact:
Steven Macina, Site 1104
714-999-6688

Inland Psychiatric Medical Group (IPMG)-Chino
Chino 5336537, California 5332921 91710
Contact:
Nandita Puchakayala, Site 1244
909-488-9116

Long Beach Research Institute, LLC
Long Beach 5367929, California 5332921 90805
Contact:
Ashley Duzik, Site 1230
562-471-3773

USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
Los Angeles 5368361, California 5332921 90033-5313
Contact:
Lon Schneider, Site 1226
323-442-3715

ATP Clinical Research-302 W La Veta Ave
Orange 5379513, California 5332921 92866
Contact:
Gustavo Alva, Site 1001
949-354-5353

NRC Research Institute - Orange - PPDS
Orange 5379513, California 5332921 92868-2847
Contact:
Daniel Chueh, Site 1228
714-289-1100

SC3 Research - Pasadena - 960 E. Green St
Pasadena 5381396, California 5332921 91106
Contact:
M. Lorraine Purino, Site 1043
626-250-2070

Prospective Research Innovations 8577 Haven Ave
Rancho Cucamonga 5385955, California 5332921 91730
Contact:
Tarek Ezzeddine, Site 1213

University of Connecticut Health Center
Farmington 4834272, Connecticut 4831725 06030
Contact:
Neha Jain, Site 1222
860-790-7354

Genesis Trust Research Group
Atlantis 4146372, Florida 4155751 33462
Contact:
Rodolfo Trejo, Site 1225
561-509-9956

Envision Trials LLC
Bonita Springs 4148533, Florida 4155751 34134
Contact:
Daniel Mandri, Site 1020
305-819-2909

JY Research Institute Inc
Cutler Bay 6332309, Florida 4155751 33189-1230
Contact:
Suez Oramas Mingo, Site 1138
305-424-8696

Arrow Clinical Trials
Daytona Beach 4152872, Florida 4155751 32117-5532
Contact:
David Billmeier, Site 1023
386-278-8000

Quantum Laboratories, Inc - West Palm Beach Office
Deerfield Beach 4153071, Florida 4155751 33442
Contact:
Jose De La Gandara, Site 1224
954-786-7331

Integrity Clinical Research, LLC - 8000 NW 21st St
Doral 4153471, Florida 4155751 33122-1620
Contact:
Lucinda Cuervo-Ramos, Site 1164
305-888-0410

New Life Medical Research Center -3750 W 16th Ave
Hialeah 4158476, Florida 4155751 33012-4648
Contact:
Jorge Betancourt, Site 1120
305-456-7782

Research in Miami, Inc
Hialeah 4158476, Florida 4155751 33013
Contact:
Dolores Sanchez Cazau, Site 1237
305-889-6670

Nexus Clinical Research Center- NRC
Homestead 4159050, Florida 4155751 33030
Contact:
John Cintron, Site 1229

K2 Medical Research - Lady Lake
Lady Lake 4161118, Florida 4155751 32159
Contact:
Craig Curtis, Site 1040
407-426-9299

Homestead Associates in Research Inc
Miami 4164138, Florida 4155751 33032
Contact:
Angel Carrasco, Site 1159
786-422-7374

Premier Clinical Research Institute
Miami 4164138, Florida 4155751 33122-1335
Contact:
Emelina Arocha, Site 1021
305-445-5994

Wellness Research Center Inc - Miami
Miami 4164138, Florida 4155751 33135-1601
Contact:
Brian Villa, Site 1125
786-238-7099

A & D Doctor Center
Miami 4164138, Florida 4155751 33135-2968
Contact:
Yordan Orive Gomez, Site 1236
305-223-2000

Floridian Neuroscience Institute-1901 SW 1 St
Miami 4164138, Florida 4155751 33135
Contact:
Emilio Mantero-Atienza, Site 1115
305-326-0776

Miami Jewish Health Systems
Miami 4164138, Florida 4155751 33137
Contact:
Marc Agronin, Site 1010
3057518626x2403

MedOne Clinical Research LLC
Miami 4164138, Florida 4155751 33145-2455
Contact:
Thierry Jacquemin, Site 1143
305-359-7666

My Community Research Center, Inc - 7480 Bird Rd
Miami 4164138, Florida 4155751 33155-6630
Contact:
Cesar Guerrero, Site 1113
786-359-4867

Future Care Solution LLC
Miami 4164138, Florida 4155751 33165-3947
Contact:
Pilar Trueba, Site 1129
305-888-0410

Reliant Medical Research
Miami 4164138, Florida 4155751 33165
Contact:
Carlos Ramirez Calderon, Site 1150
786-801-0912

Novel Clinical Research Center, LLC.
Miami 4164138, Florida 4155751 33173-1474
Contact:
Heber Varela, Site 1006
000-000-0000

Dade Research Center - Miami FL - 7600 SW 87th Ave
Miami 4164138, Florida 4155751 33173
Contact:
Maria Nualart, Site 1111
208-346-8900

US Associates in Research Inc
Miami 4164138, Florida 4155751 33175
Contact:
Christopher Jimenez, Site 1158
305-246-0873

Serenity Research Center
Miami 4164138, Florida 4155751 33176-1451
Contact:
Sergio Jaramillo, Site 1235
305-596-2080

IMIC LLC- 9380 SW 150th Str
Miami 4164138, Florida 4155751 33176-7947
Contact:
Leon Ramon, Site 1147
786-600-7005

New Gen Health
Miami 4164138, Florida 4155751 33176
Contact:
Roberto Hernando, Site 1234
305-892-1035

Floridian Research Institute-1021 Ives Dairy Rd
Miami 4164138, Florida 4155751 33179-2537
Contact:
Gretel Trullenque, Site 1105
786-391-1137

High Quality Research
Miami 4164138, Florida 4155751 33184-1412
Contact:
Jorge Gonzalez, Site 1157
305-392-0244

New Med Research
Miami Gardens 4164167, Florida 4155751 33056-4000
Contact:
Marta Fernandez, Site 1126
305-269-7100

Panax Clinical Research
Miami Lakes 4164186, Florida 4155751 33014
Contact:
Robert Perry, Site 1209
305-698-4500

Angels Clinical Research Institute - Miami Lakes - Palm Springs - PPDS
Miami Lakes 4164186, Florida 4155751 33016
Contact:
Yanely Pineiro Puebla, Site 1118
786-218-1733

Aqualane Clinical Research
Naples 4165565, Florida 4155751 34105
Contact:
William Justiz, Site 1246
941-436-6838

Sensible HealthCare, LLC
Ocoee 4166776, Florida 4155751 34761-2964
Contact:
Kelly Taylor, Site 1212
407-654-2724

Nova Psychiatry
Orlando 4167147, Florida 4155751 32803
Contact:
David Medina, Site 1242
407-823-8421

Combined Research Orlando Phase I-IV LLC
Orlando 4167147, Florida 4155751 32807-3555
Contact:
Eric Carbonell, Site 1112
407-440-4493

Neurology Associates of Ormond Beach
Ormond Beach 4167178, Florida 4155751 32174-3101
Contact:
David McDonald, Site 1204
386-673-2500

Progressive Medical Research (Duplicate)
Port Orange 4169156, Florida 4155751 32127
Contact:
Alexander White, Site 1205
386-304-7070

Cordova Research Institute- Sweetwater
Sweetwater 4174600, Florida 4155751 33182
Contact:
Delores Macksoud, Site 1133
786-631-3890

Angels Clinical Research Institute Tampa - Palm Springs - PPDS
Tampa 4174757, Florida 4155751 33614-2869
Contact:
Al Robaina, Site 1123
813-931-0128

Guardian Angel Research
Tampa 4174757, Florida 4155751 33614
Contact:
Sadaf Bazargan, Site 1124
813-300-3300

Interventional Psychiatry of Tampa Bay
Tampa 4174757, Florida 4155751 33629-5837
Contact:
Jamie Fernandez, Site 1110
813-251-1800

Premiere Research Institute at Palm Beach Neurology, PA
West Palm Beach 4177887, Florida 4155751 33407-3209
Contact:
Paul Winner, Site 1216
561-845-0500

Agile Clinical Research Trials, LLC
Atlanta 4180439, Georgia 4197000 30328-5532
Contact:
Vasundhara Cheekati, Site 1206
404-382-8660

McLean Hospital
Belmont 4930282, Massachusetts 6254926 02478-1064
Contact:
Arkadiy Stolyar, Site 1223
617-855-2136

Tufts Medical Center - 800 Washington St - PPDS
Boston 4930956, Massachusetts 6254926 02111-1552
Contact:
Brent Forester, Site 1245
617-636-3108

Boston Neuro Research Center
North Dartmouth 4945601, Massachusetts 6254926 02747-2612
Contact:
Mushtaque Chachar, Site 1243
508-925-7403

Elixia Health - Springfield - Elixia - PPDS
Springfield 4951788, Massachusetts 6254926 01103
Contact:
Susan Smiga, Site 1239
413-305-1142

Neurobehavioral Medicine Group (NBMG)
Bloomfield Township 7259551, Michigan 5001836 48302-1909
Contact:
Richard Jackson, Site 1248
412-916-2425

Precise Research Centers
Flowood 4426822, Mississippi 4436296 39232
Contact:
Joseph Kwentus, Site 1132
601-420-5810

Advanced Memory Research Institute - CenExel - PPDS
Toms River 4504476, New Jersey 5101760 08755
Contact:
Arun Singh, Site 1202
732-341-9500

Bio Behavioral Health
Toms River 4504476, New Jersey 5101760 08755
Contact:
Ashok Patel, Site 1232
732-244-2299

Five Towns Neurology, PC
Woodmere 5145028, New York 5128638 11598-1739
Contact:
David Steiner, Site 1025
516-239-1800

Triad Clinical Trials - 515 College Rd
Greensboro 4469146, North Carolina 4482348 27410-3311
Contact:
Richard Montgomery, Site 1221
336-235-0991

AMC Research, LLC - Flourish - PPDS
Matthews 4478334, North Carolina 4482348 28105-8336
Contact:
Mohammad Bolouri, Site 1214
704-364-4000

West Clinical Research
Morehead City 4480153, North Carolina 4482348 28557
Contact:
Patrick Morgante, Site 1215
252-515-0050

Ohio State University
Columbus 4509177, Ohio 5165418 43221
Contact:
Douglas Scharre, Site 1201
614-293-4560

Insight Clinical Trials LLC - Independence
Independence 5158404, Ohio 5165418 44131
Contact:
Mark Stillman, Site 1249
216-444-8897

The Rivus Wellness & Research Institute
Oklahoma City 4544349, Oklahoma 4544379 73112
Contact:
Marvin Peyton, Site 1016
405-317-5783

Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02903
Contact:
Chuang-Kuo Wu, Site 1218
714-456-7002

Vanderbilt Psychiatric Hospital
Nashville 4644585, Tennessee 4662168 37212-3133
Contact:
Jo Wilson, Site 1211
615-322-4967

Epic Medical Research LLC - DeSoto - HyperCore - PPDS
DeSoto 4685524, Texas 4736286 75115-2043
Contact:
Haresh Boghara, Site 1121
972-777-6956

Advanced Neuro Research Center - El Paso
El Paso 5520993, Texas 4736286 79912-1743
Contact:
Aamr Herekar, Site 1208
505-903-1715

AIM Trials
Plano 4719457, Texas 4736286 75093-8225
Contact:
Sejal Mehta, Site 1238
972-267-1988

Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
San Antonio 4726206, Texas 4736286 78229-3901
Contact:
Antonio Teixeira, Site 1210
210-567-8229

R & H Clinical Research-3727 Greenbriar Dr
Stafford 4734005, Texas 4736286 77477-3929
Contact:
Mustafa Zaidi, Site 1134
832-356-3238

Conquest Research - Arlington
Arlington 4744709, Virginia 6254928 22205
Contact:
Henry Tran, Site 1241
703-717-7755

Santa Cruz Behavioral PSC
Bayamón 4562831, Puerto Rico 00961-6910
Contact:
William Julio De Jesus, Site 1303
7877984592

CDT Grupo Medico San Pablo Inc.
Bayamón 4562831, Puerto Rico 961
Contact:
Ismael Toro-Grajales, Site 1301
8888888888

Instituto De Neurologia Dra. Ivonne Fraga,Psc
San Juan 4568127, Puerto Rico 00918-4502
Contact:
Ivonne De L Fraga Berrios, Site 1302
7874035534

Barbara Diaz Hernandez MD Research Inc
San Juan 4568127, Puerto Rico 00926-3160
Contact:
Ileana Fumero-Perez, Site 1304

More Details

Status
Recruiting
Sponsor
Karuna Therapeutics

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com